FDA 483 - Baxter Healthcare Corporation - February 05, 2010

This FDA Form 483 document outlines several significant observations made during an inspection, indicating deficiencies in the facility's manufacturing processes and quality control systems.

**Facility and Operation Details:** The document does not provide specific details about the facility's name, location, or the type of drug product being manufactured. However, it clearly pertains to a drug manufacturing operation subject to FDA regulations.

**Violations and Observations:** 1. **Process Validation Deficiency:** Control procedures are not established to validate the performance of manufacturing processes. This indicates a lack of assurance that the processes consistently produce in-process materials and drug products with desired characteristics, potentially leading to variability. 2. **Equipment Maintenance Records:** Records for the maintenance and inspection of equipment are not being kept. This is a critical lapse as it prevents tracking equipment performance, identifying potential issues, and ensuring equipment is fit for purpose, which can directly impact product quality. 3. **Inadequate Acceptance Criteria:** The acceptance criteria used by the quality control unit for sampling and testing are not adequate. This means the criteria are insufficient to ensure that batches of drug products consistently meet all appropriate specifications before approval and release, posing a risk of non-conforming products reaching the market. 4. **Non-Conforming Product Control:** Products that do not conform to specifications are not adequately controlled. This suggests a failure in the system to properly identify, segregate, and manage defective products, increasing the risk of their accidental release